Trial Outcomes & Findings for Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease (NCT NCT03694652)
NCT ID: NCT03694652
Last Updated: 2023-05-26
Results Overview
Walking distance as measured by the 6 minute walk test.
COMPLETED
NA
29 participants
Month 3
2023-05-26
Participant Flow
Participant milestones
| Measure |
PACE+DApp
Participants in this group will receive a physical activity and dietary intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program to promote physical activity
Diet: Motivating healthy dietary habits
App: Using an app to deliver communication to the participant.
|
Motivational Interviewing
Participants in this group will receive motivational interviewing - in-person and via telephone.
Motivational Interviewing: Motivational interviewing counseling is used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Baseline characteristics by cohort
| Measure |
PACE+DApp
n=13 Participants
Participants in this group will receive a physical activity and dietary intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program to motivate physical activity
Diet: Motivating healthy dietary habits
App: Used to deliver the interventions
|
Motivational Interviewing
n=16 Participants
Participants in this group will receive counseling - motivational interviewing.
Motivational interviewing was used to motivate physical activity and health dietary habits
MI was delivered face-to-face initially followed by telephone for subsequent sessions (total sessions were 5)
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.12 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
68.39 years
STANDARD_DEVIATION 7.36 • n=7 Participants
|
66.03 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Walking distance as measured by the 6 minute walk test.
Outcome measures
| Measure |
PACE+DApp
n=11 Participants
Participants in this group will receive combined intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program was used to motivate physical activity
Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks)
App: The app was used to deliver both physical activity and healthy dietary habits.
|
Motivational Interviewing
n=14 Participants
Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions.
Motivational interviewing was used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Walking Distance
|
331.19 meters
Standard Deviation 58.63
|
298.67 meters
Standard Deviation 101.20
|
SECONDARY outcome
Timeframe: Month 3Change in weight, collected at two time points.
Outcome measures
| Measure |
PACE+DApp
n=11 Participants
Participants in this group will receive combined intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program was used to motivate physical activity
Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks)
App: The app was used to deliver both physical activity and healthy dietary habits.
|
Motivational Interviewing
n=14 Participants
Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions.
Motivational interviewing was used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Weight Loss
|
2.3 lbs.
Interval 0.7 to 3.4
|
10.1 lbs.
Interval 3.0 to 17.9
|
SECONDARY outcome
Timeframe: Month 3QoL as measured by the Vascular Quality of Life Questionnaire. There are 25 questions that are each scored 1-7. The total score is determined by all adding the score from each of the 25 questions and dividing by 25. The total range is 1-7 and a higher score indicates a better quality of life.
Outcome measures
| Measure |
PACE+DApp
n=11 Participants
Participants in this group will receive combined intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program was used to motivate physical activity
Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks)
App: The app was used to deliver both physical activity and healthy dietary habits.
|
Motivational Interviewing
n=14 Participants
Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions.
Motivational interviewing was used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Quality of Life (QoL)
|
5.09 units on a scale;
Standard Deviation 1.37
|
5.36 units on a scale;
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Month 3Physical activity to be measured using the Exercise Behavior Questionnaire from the Stanford Patient Education Research Center. Scores are for type of activity, length of activity, time spent in aerobic activities, and an assessment of time spent in stretching and strengthening exercises. For the manuscript, we only focused on aerobic activity and we did not include stretching or strengthening exercise scores. Participants were asked how often during the past week they performed aerobic exercises on a scale of 0 (none) to 4 (more than 3 hours per week). Scores were converted by the overall time spent in aerobic exercises per week and range from 0 to 180 with higher scores indicating more time spent doing aerobic exercises.
Outcome measures
| Measure |
PACE+DApp
n=11 Participants
Participants in this group will receive combined intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program was used to motivate physical activity
Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks)
App: The app was used to deliver both physical activity and healthy dietary habits.
|
Motivational Interviewing
n=14 Participants
Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions.
Motivational interviewing was used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Physical Activity
|
22.73 units on a scale
Standard Deviation 16.56
|
27.32 units on a scale
Standard Deviation 27.18
|
SECONDARY outcome
Timeframe: Month 3Dietary habits tracked using the Fat-Related Diet Habits Questionnaire. Questions were rated on a 4-point scale, where 1 indicates healthy and 4 less healthy eating habits. The questionnaire included five sections (i) replacing high fat foods with low fat substitutes (score range: 7-28); (ii) modifying high fat foods (range: 3-12); (iii) avoiding high fat cooking methods (score range: 4-16); (iv) consumption of fresh fruit and vegetables as a snack (score range: 3-12); and (v) choosing specially manufactured low fat food (score range: 5-20). The total score is calculated from the sum of section scores divided by 5 (range from 4.4 to 17 with higher scores representing more unhealthy eating habits)
Outcome measures
| Measure |
PACE+DApp
n=11 Participants
Participants in this group will receive combined intervention via a mobile phone app.
PACE: Patient-centered Assessment and Counseling for Exercise \[PACE\] program was used to motivate physical activity
Diet: health dietary habits (reducing sodium, increasing fruits and vegetables, increasing whole grains, mindful eating, decreasing sugary drinks)
App: The app was used to deliver both physical activity and healthy dietary habits.
|
Motivational Interviewing
n=14 Participants
Participants in this group will receive counseling (motivational interviewing) an initial face-to-face session followed by four phone sessions.
Motivational interviewing was used to promote physical activity and healthy dietary habits.
|
|---|---|---|
|
Dietary Habits
|
2.61 score on a scale
Standard Deviation 0.32
|
2.45 score on a scale
Standard Deviation 0.52
|
Adverse Events
PACE+DApp
Motivational Interviewing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place